The oral administration of pharmaceutical formulations comprising an active pharmaceutical ingredient with an unpleasant taste remains a technical challenge. However, treatment of diseases often requires to ingest substances comprising an active agent. Certain agents for oral application have an unwanted taste. In addition, some agents have to be applied in substantial amounts. Further, it is important to deliver a predefined dosage, any agents remaining on the delivery device or being spilled substantially impair the desired medical or nutritive effect. Since a number of active substances can not be stored for a long time if dissolved with or exposed to water and have to be stored in dry condition, the composition is delivered in water-free form. This requires the patient to add water before application. Since the patient is required to prepare the formulation by adding water, the formulation and any means for application are required to be easy to handle and should not lead to a wrong dosage, if the patient inaccurately uses the means for application.
According to a first approach, the formulations are applied in semi-solid form, i.e. in the form of a gel or with the consistence of a pudding in order to reduce the effect of the unwanted taste. Thus, the active agent is combined with a gelling agent providing the semi-solid consistence. Further, this can be combined with substances for taste masking which are added to the formulation. In particular, taste masking is effective when combined with a semi-solid texture of the formulation. For administering, water is added to the combination of active composition and gelling agent. Due to the sensitivity with regard to water, the semi-solid formulation can not be stored for a long time, and, consequently water has to be added by the patient upon application.
In WO 2005/107713 A2 a solution according to a first approach is described. A spoon is disclosed, which contains the active composition combined with e.g. Gellan gum. For storing, the spoon is sealed with a “peel-off” film, which encloses the active composition (and the Gellan gum) together with the sealing layer. Upon application, the peel-off film is completely removed before water is added. The added water takes a certain time period (typically 5 min) to enter the gum and to build the semi-solid form within the opened spoon. After this time period, the formulation can be applied.
In this formulation, the active composition and the gum form one solid body attached to the spoon to obviate the loss of any active composition before and during the application and during the absorption of water. Thus, the solid body containing the gum has low specific surface areas involving a long diffusion/absorption process during which the water enters the gum. However, since all of the active composition has to be attached to the spoon to avoid spoiling, no structure for the active substance/gum can be selected enabling a shorter diffusion process. In particular, during this (necessarily) long diffusion/absorption process, neither dissolved amounts of active composition nor dissolved amounts of gum are secured against spoiling. Since the spoon presents the semi-solid formulation at an open surface, any accidental move or agitation, even very light impacts, bear the risk of spoiling a part of the formulation. In particular, tilting the spoon after some water has changed the formulation to a semi-solid state leads loss of the formulation. Since the formulation is given in a predefined amount related to e.g. to a single dosage, this would lead to an incorrect dosage applied to the patient.
According to a second approach, the substance relevant to nutrition or to medical treatment is given as powder or in granular form. For application, a consumable fluid like water or fruit juice is added and, together with the substance, forms a suspension. Firstly, the substance provided as powder or in granular form induces the risk of spilling a part of the substance. Secondly, a part of the substance might adhere to the application device, e.g. the bottom of a drinking glass or a spoon used for introducing the substance and for stirring. Further, a part of the substance might remain in the application device due to sedimentation of the substance. Therefore, this approach bears the risk of unpersuasively reducing the dosage. Further, parts of powder or granules can easily be spilled even by careful handling. In particular this is the case when applying the substance to children or handicapped persons.
Both, the first and the second approach show bear the risk of unpersuasively reducing the dosage and require high attention upon preparation.
Therefore, it is an object of the invention to provide a device for oral application which is easy to handle, and in particular having a reduced the risk of spoiling active agent upon preparation.